Our client, an established and quickly growing biotech company located in the RTP, NC area, is presently seeking candidates for a Clinical Research Scientist opportunity. The incumbent will be largely responsible for providing guidance and operational support to clinical studies ensuring that studies are properly executed and comply with all regulations.
This is a direct hire full-time opportunity offering tremendous career growth, a competitive salary plus bonus, as well as attractive employee ...
We are looking for CRAs with at least 6 years monitoring experience and 3-4 years in Oncology . .
MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits). Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations. Maintains regular review of site regulatory binder and ensures proper storage, ...
Regulatory Medical Writer
Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms
Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical ...
Note: Candidates must possess Ph. 1 and 2 Full Service Oncology PM Experience
The Clinical Operations Senior Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing MedSource or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines. In-depth knowledge and experience of the drug development process is required, including study initiation, clinical ...
• The CDS will support the Company’s regulatory function and study team in the document management of clinical research trials from the project development stage through to project completion. Mainly, the CDS will perform a variety of research, database, and administrative duties of a routine and technical nature in support of clinical trials to assist investigators in organizing, gathering, and compiling clinical research data.
DUTIES AND RESPONSIBILITIES:
• Assist with collecting, ...
The CPA will support the clinical project managers and study team in the administrative project management of clinical research trials from the project development stage through to project completion.
DUTIES AND RESPONSIBILITIES:
• Provides project management support including preparation of scope documents, follow-up on project timelines and deliverables, and project participation.
• Manage active study files (central files) and prepare key documents for archiving according to client ...
• The Regulatory Affairs Specialist supports the Company’s regulatory function and project teams through the provision of a variety of administrative and technical tasks involving the management of clinical research trials documentation. In addition, the Regulatory Affairs Specialist performs a variety of research, database, and administrative duties of a routine and technical nature in support of corporate initiatives and clinical trials to assist MedSource and/or clients in organizing, ...
Desired Skills & Experience
• College/University degree in life sciences, RN preferred
• At least 5 years of prior industry experience
• At least 2 years of experience at a position of Clinical Project Manager
• Previous CRO experience required
• Therapeutic experience - Oncology.
• Participation in at least three clinical research projects in the capacity of a Clinical Project Manager
• Proficiency in standard MS Office ...
Brio Resource Group is seeking a Quality Assurance Manager GCP/GMP Operations for an emerging pharmaceutical company located in the Raleigh/Durham, NC area.
The QA Manager will be responsible for Clinical Trial Development projects and additional Quality Assurance Manufacturing activities.
-Responsible for Clinical Supplies batch record review providing final release for use in clinical trials
-Quality Assurance contact for deviations and failures
-Clinical vendor selection
We are currently looking to hire Permanent Regional CRAs
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, ...
Mar 10 -
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